Studies of Brain and Body Interaction

NCT03672266 | Completed

• 1 other identifier: BrainBody
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to characterize biophysiolgoical signals as a comprehensive profile of the nervous systems in order to understand interactions between the brain and body, while an individual performs naturalistic behaviors (ex. walking, pointing) and while breathing at a slow controlled pace. The investigators aim to study these interactions among a variety of populations, from healthy individuals to those with disorders such as Autism Spectrum Disorder(s), including those who may also have an ADHD (Attention-deficit/hyperactivity disorder) diagnosis, Asperger's Syndrome, Alzheimer's Disease, and/or Fragile X syndrome

Conditions

Autistic Disorders Spectrum; Asperger Syndrome; Alzheimer Disease; Parkinson; Tremor Essential; Dementia, Alzheimer Type; Dementia With Lewy Bodies; Dementia Frontal; Lewy Body Dementia With Behavioral Disturbance (Disorder); Adhd

Outcome Measures

Primary Outcomes (1)

• Unitless Stochastic Signatures of Biophysiological Signals, consisting of the Empirically Estimated Shape and Dispersion (scale) Parameters of Probability Distribution Functions

  Biophysical signals extracted from the brain and heart (mV) and motor kinematics (m/s) activities will be normalized and scaled to a unit-less waveform dataset. The standardized unitless data set will account for anatomical differences and will then be empirically characterized as families of probability distributions for each person, by the shape and scale parameters of continuous families of probability distribution functions with variable shapes and dispersion (noise to signal ratio). These parameters are objective biomarkers for a variety of disorders, and inform the level of noise-to-signal ratio and predictability of an individual's biorhythms (Torres, 2018). Torres, E. (2018). Objective Biometric Methods for the Diagnosis and Treatment of Nervous Systems Disorder: Elsevier

  through study completion, an average of 1 year

Secondary Outcomes (2)

• Brain and Body Connectivity metrics and Derived Geometric and Topological Indexes from the Network Connectivity Model and Inverse Kinematic Model

  through study completion, an average of 1 year

• Information theoretic metric

  through study completion, an average of 1 year

Study Arms (2)

Neurological Disorder

Individuals with neurological disorders such as Autism Spectrum Disorder(s), including those who may also have an ADHD diagnosis, Asperger's Syndrome, Alzheimer's Disease, Fragile X syndrome, Parkinson's disease, Lewy Body Dementia, and/or Frontoparietal Dementia

Neurotypical

Healthy individuals with no known neurological disorders

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

No restriction from which the cohort will be selected

You may qualify if:

• Clinical diagnosis of any one of the following:
• Autism Spectrum Disorder(s)
• ADHD
• Asperger's syndrome
• Alzheimer's disease
• Fragile X syndrome
• Parkinson's disease

Sponsors & Collaborators

• Rutgers University: lead

Study Sites (1)

Rutgers University

Piscataway, New Jersey, 08854-8020, United States

Location

MeSH Terms

Conditions

Child Development Disorders, Pervasive; Attention Deficit Disorder with Hyperactivity; Asperger Syndrome; Alzheimer Disease; Essential Tremor; Lewy Body Disease

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Autism Spectrum Disorder; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Synucleinopathies

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 7, 2018
• First Posted: September 14, 2018
• Study Start: August 1, 2018
• Primary Completion: December 1, 2025
• Study Completion: December 25, 2025
• Last Updated: April 29, 2026

Record last verified: 2025-10

Locations

US (1)